Mergers and Acquisitions

* On August 5, 2013, The Medicines Company has announced that it has purchased all of the outstanding equity of ProFibrix for $90 million at the closing held today and agreed to pay ProFibrix equityholders up to an additional $140 million upon the achievement of agreed-upon U.S. and European regulatory approvals and sales milestones. The acquisition was subject to The Medicines Company’s satisfactory review of the pending Phase 3 clinical trial results of ProFibrix’s lead biologic, Fibrocaps™, a dry powder topical formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery. The Phase III trial, FINISH-3, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. The Medicines Company expects the results of FINISH-3, which was conducted at 65 sites across the U.S. and Western Europe, to support a biologics license application (BLA) with the FDA, and a marketing authorisation application (MAA) with the European Medicines Agency. ProFibrix has also developed a complementary dry powder spray delivery device to assist surgeons in the accurate application of Fibrocaps. Recently the ProFibrix quality management system for the design, development and control of manufacture of sterile biological hemostat delivery systems and their accessories was granted ISO 14385: 2003 certification. Applications for a European CE mark and for an FDA 510k review for the device are underway.

The Medicines Company anticipates peak Fibrocaps revenues of greater than $300 million if approved in major markets. The Company expects one time deal costs and incremental operating expenses, including transaction costs and amortization of intangibles to be approximately $9-12 million in the third quarter 2013.
* On June 4, 2013, The Medicines Company and ProFibrix have announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix subject to The Medicines Company's satisfactory review of the pending Phase 3 clinical trial results of ProFibrix's lead biologic, Fibrocaps™.

Fibrocaps is a dry powder topical formulation of fibrinogen and thrombin being developed to stop bleeding during surgery. The Phase 3 trial, FINISH-3, has completed enrollment of 719 surgical patients with mild to moderate surgical bleeding. Results of FINISH-3 are expected in the third quarter of 2013. If the results are favorable, FINISH-3 is expected to be sufficient to support a BLA filing in the United States and an MAA filing with the European regulatory authorities.

Under the terms of the agreement, The Medicines Company will pay ProFibrix a $10 million upfront option payment. If the Medicines Company is satisfied with the trial results of FINISH-3 and determines to proceed, it will purchase all of the outstanding capital stock of ProFibrix at closing. Otherwise, The Medicines Company may terminate the transaction with no further obligation to the ProFibrix shareholders. ProFibrix shareholders could receive additional payments related to achieving US and European regulatory approvals and sales milestones. The transaction is subject to the satisfaction of customary closing conditions.

BofA Merrill Lynch served as financial advisor and WilmerHale served as legal advisor for the transaction for The Medicines Company. Barclays served as financial advisor and Dechert served as legal advisor for the transaction for ProFibrix.